Withings finally gets ScanWatch FDA clearance for US release

Regulators, mount up
Withings ScanWatch heading to the US
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Withings has finally received FDA clearance for its ScanWatch hybrid smartwatch, and with it the green light to bring it to the US.

The French company launched the ScanWatch in Europe back in 2020, and received clearance from the CE for its ECG and sleep apnea detection.

But the company ran into a regulatory brick wall with the FDA, which prevented it from going on sale in the US.

But that’s now changed – and the ScanWatch will be available to buy in the US from November. However, there's no word on whether the new ScanWatch Horizon or cheaper Withings Move ECG will get a release.

The Withings ScanWatch received a rave review in its Wareable test, and it’s one of our top health smartwatches, thanks to its mix of superb data, analysis, sensors and battery life.

ScanWatch hybrid smartwatch

In true Withings style, it’s a hybrid smartwatch, which means that all the smart stuff is hidden behind an analogue face with actual hands.

It does have a small OLED display to give feedback on your stats and some basic notifications – but the lack of a massive screen means it offers a month of battery life while offering full health tracking.

The Withings ScanWatch has ECG, which will spot check your heart rhythm for irregularity that could be a sign of Afib.

Likewise, it will also keep tabs on blood oxygen levels and breathing disturbances at night and warn you whether you’re experiencing mild or severe apnea events.

While monitoring blood oxygen through sleep is a feature of Apple, Fitbit and other devices – few link the data to sleep apnea specifically because of a lack of FDA clearance.

The Withings ScanWatch will cost $279 for the 38mm and $299 for the 42mm when it goes on sale. That obviously a decent saving over the Apple Watch Series 7, and puts it in line with the Fitbit Sense – both of which feature ECG.